Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
데이터 추가 비고
원인
Based on customer complaints that the material was not fully polymerizing an analysis of the retained sample confirmed that batch s09397 does not meet the specification in terms of curing depth. (specification >>=2.0mm test result 1.74mm). a chemical analysis showed that the amine initiator (ethyl p-dimethylamino benzoate) was not present in the material (expected 0.4% result <0.002%). the other initiator used in the material campherquinone was present in the material. the lack of amine initiator could result in the material curing inadequately.